MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM TWIST DRILL WITH J NOTCH

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill tip fractured during a zygomatic fracture open reduction and fixation.There were no consequences or impact to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned twist drill.The drill shows signs of use including marking/ scratches on the bit surface.The drill bit has fractured near where the drill flutes meet the twist drill base.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH
• Common Device Name: DRILL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14843142
• Report Number: 0001032347-2022-00210
• Device Sequence Number: 20224440
• Product Code: HBE
• UDI-Device Identifier: 00841036013165
• UDI-Public: (01)00841036013165(10)319173
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-7144
• Device Lot Number: 319173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 08/05/2022; 11/23/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/18/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown